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A multicenter, randomized, double-blind, placebo-controlled phase III clinical study of jaktinib hydrochloride tablets in the treatment of adult patients with moderate and severe atopic dermatitis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Jaktinib low dose | Experimental | Low dose |
|
| Jaktinib high dose | Experimental | High dose |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jaktinib Hydrochloride Tablet | Drug | Orally administered, twice a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| The efficacy in the treatment of moderate and severe atopic dermatitis | The proportion of subjects whose Eczema Area and Severity Index (EASI) total score decreased by ≥ 75% from baseline | 16 weeks |
| The efficacy in the treatment of moderate and severe atopic dermatitis | The proportion of subjects with a systemic Investigator's Global Assessment (IGA) score of 0 or 1 and a decrease of ≥ 2 points from baseline | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The abnormal laboratory values and/or adverse events in the treatment of moderate and severe atopic dermatitis | Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment | up to 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Wu | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 139 People's Middle Road | Changsha | Hunan | 410008 | China |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |